Senior Clinical Trial Manager, PKU

Role Summary

As a Senior Clinical Trial Manager (Sr. CTM) at Maze Therapeutics, you’ll play a hands‑on role in driving the execution of our clinical trials. You’ll have the opportunity to lead early- to mid‑stage clinical studies, work cross‑functionally with internal teams and external partners, and ensure trials run efficiently and with the highest quality standards.

• Clinical Trial Execution & Leadership
  • Co‑lead operational activities of a mid‑stage clinical trial, ensuring high‑quality execution from study design to completion. Manage a Study Execution Team (SET) alongside the Study Lead, from protocol development to completion of key study milestones (FPI, enrollment completion, interim analysis, database lock, and final CSR).
  • Maintain active, hands‑on oversight of CRO operations by closely tracking study progress, evaluating risks, and intervening early to course‑correct.
  • Apply a solution‑oriented mindset to optimize study processes, boost study recruitment, and strengthen vendor/site performance.
• Vendor, CRO & Site Management
  • Provide strategic sponsor oversight of the global CRO monitoring team, guiding the CRO Global CTM and CRAs to ensure alignment with study timelines, recruitment targets, and high‑quality data delivery. Initiate methods to better build relationships with sites, address issues, and ensure on‑track enrollment and data entry.
  • Lead end‑to‑end vendor management for all clinical trial vendors, including vendor identification and selection, budget and contract negotiations, onboarding, and ongoing operational oversight, ensuring compliance with study protocols, contracted scope, and ICH‑GCP requirements.
  • Develop and manage study‑specific plans including site monitoring strategies, blinding plan, etc. Experienced in organizing DMCs, managing clinical trial budgets, and review clinical data listings and summary tables.
• Budget & Financial Oversight
  • Support Clinical Operations Leadership with study‑specific budget tracking and vendor spend management.
• Data Quality, Compliance & Regulatory Readiness
  • Ensure clinical trial data integrity and adherence to protocols, SOPs, and ICH‑GCP guidelines through oversight of CROs, vendors, and site monitoring activities.
  • Partner with Quality Assurance on inspection readiness efforts.
• Process Optimization & Technology Implementation
  • Contribute to evaluating and implementing clinical trial systems (e.g., eTMF, CTMS, RBM) to enhance efficiency.
  • Assist in developing SOPs and scalable processes for clinical operations.
• Cross‑functional Collaboration
  • Partner with cross‑functional teams like Biostatistics and Clinical science to identify and onboard new study vendors and systems (e.g. ARGUS).
  • Partner with internal teams, such as CMC and Clinical Supply Chain, to manage study drug supply and distribution. Work closely with other functions to ensure smooth study execution.

• A Bachelor’s degree in a scientific discipline or health related field with 5–8 years of clinical operations experience, including at least 4 years as a CTM, with hands‑on experience managing Phases I–III clinical trials. Global trial experience is a plus.
• Experience in common disease and/or rare disease drug development.
• Familiarity with regulatory guidelines (FDA, EMA, ICH‑GCP).
• Experience conducting a broad range of clinical trial related activities including study start‑up to study close‑out, clinical trial databases (e.g., Medidata RAVE, Veeva), knowledge of clinical trial budgeting, and managing CROs and vendors.
• Strong executional leadership, problem‑solving skills, and ability to manage cross‑functional teams at the study level.
• A startup mindset, willingness to roll up sleeves, and ability to work in a fast‑paced, evolving, and collaborative team environment.
• Excellent communication skills and the ability to manage cross‑functional relationships effectively.
• Are willing to travel up to 30% to support study needs.

• Bachelor’s degree in a scientific discipline or health‑related field.

• Willingness to travel up to 30% to support study needs.